UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038938 |
|---|---|
| Receipt number | R000044406 |
| Scientific Title | Development of a predictive strategy for the detection of the patients with high risk for delirium |
| Date of disclosure of the study information | 2020/01/24 |
| Last modified on | 2022/09/14 16:38:12 |
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Basic information
Public title
Development of a predictive strategy for the detection of the patients with high risk for delirium
Acronym
Deep Study
Scientific Title
Development of a predictive strategy for the detection of the patients with high risk for delirium
Scientific Title:Acronym
Deep Study
Region
| Japan |
Condition
Condition
Malignant tumors
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study designs to develop a predictive strategy for the detection of the patients with high risk for delirium by analyzing bloods obtained from the patients who are in palliative care wards at the stage before and after the delirium onset.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of factors associated with delirium onset.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients in palliative care unit
2) Patients who are not delirium at the time of hospitalization
3) Patients who can obtain consent form
Key exclusion criteria
1) Patients who are at Delirium at the time of hospitalization
2) Patient judged by the attending physician to be inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Okawaki |
Organization
Kawasaki Medical School
Division name
Clinical Oncology
Zip code
701-0192
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
m.okawaki@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Okawaki |
Organization
Kawasaki Medical School
Division name
Clinical Oncology
Zip code
701-0192
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
m.okawaki@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama
Tel
086-462-1111
kmsrec@med.kawasaki-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 12 | Month | 20 | Day |
Last modified on
| 2022 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044406
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
